Opioid UsePhase 1NCT04300751

The Behavioral Effects of Opioids and Alcohol

A Phase 1 study testing Alcohol and Opioid Agonist in people with Opioid Use and Alcohol Drinking, run by Sharon Walsh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these… Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Opioid Use, Alcohol Drinking
What is being tested?: Alcohol and Opioid Agonist
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 24 Mar 2021to 9 Nov 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults ages 21-55
Current non-medical use of opioids
Previous alcohol use

Who cannot join

Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
Seeking treatment for drug use
Significant medical problems

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kentucky
Lexington, Kentucky, 40508

Other trials in United States

About this study

Official title: Interactions of Alcohol and Opioids: Pharmacodynamic Effects

Conditions: Opioid Use, Alcohol Drinking
Being tested: Alcohol, Opioid Agonist
Keywords: opioid, opiate, alcohol
Medical subject headings: Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlcoholDrug
Active alcohol or placebo, administered orally
Opioid AgonistDrug
Active opioid agonist or placebo, administered orally

Study groups in NCT04300751
Study group	Role	What they receive
Alcohol	Experimental	Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session. Receives: Drug: Alcohol
Opioid Agonist	Experimental	Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally Receives: Drug: Opioid Agonist
Opioid Agonist/Alcohol Combination	Experimental	Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Receives: Drug: Alcohol; Drug: Opioid Agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).
Measured: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)

Secondary outcomes (3)

Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?
Participants rated their subjective response to the question "How drunk do you feel?" on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater feeling of drunk. TThis outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).
Measured: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)
Trough Oxygen Saturation
Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Lower scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM).
Measured: Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).
Peak Cold Pressor Test Threshold
Participants immerse their forearm in cold water (1.0 +/- .5 degree Celsius) and remove their arm from the cold water to indicated pain tolerance (max 5 mins). Cold Pressor Test Threshold (time elapsed since cold water immersion measured in seconds) monitored throughout each session. Higher scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).
Measured: Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 20219 Nov 2024

First posted9 Mar 2020
Study start24 Mar 2021
Primary completion9 Nov 2024
Study completion9 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04300751
Sponsor's protocol ID: 55176
Other IDs: R01DA016718
Status last verified: Oct 2025
First submitted: 5 Mar 2020
Last updated: 20 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: We have no plans to share individual participant data with other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Use trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interactions of Alcohol and Opioids: Pharmacodynamic Effects
ClinicalTrials.gov ID: NCT04300751
Acronym / sponsor ID: 55176
Conditions: Opioid Use, Alcohol Drinking
Keywords: opioid, opiate, alcohol
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Sharon WalshUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 24 Mar 2021 (actual)
Primary completion: 9 Nov 2024 (actual)
Study completion: 9 Nov 2024 (actual)
First posted: 9 Mar 2020 (actual)
Results: Posted 20 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Alcohol	Experimental	Drug: AlcoholParticipants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.
Opioid Agonist	Experimental	Drug: Opioid AgonistParticipants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally
Opioid Agonist/Alcohol Combination	Experimental	Drug: Alcohol, Drug: Opioid AgonistParticipants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy adults ages 21-55
Current non-medical use of opioids
Previous alcohol use

Key exclusion criteria (3 listed)

Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
Seeking treatment for drug use
Significant medical problems

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlcoholActive alcohol or placebo, administered orally	Drug	Alcohol, Opioid Agonist/Alcohol Combination
Opioid AgonistActive opioid agonist or placebo, administered orally	Drug	Opioid Agonist, Opioid Agonist/Alcohol Combination

Primary outcome

Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
Time frame: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).

3 secondary outcomes

Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?
Time frame: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)
Trough Oxygen Saturation
Time frame: Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).
Peak Cold Pressor Test Threshold
Time frame: Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

Results and safety

Results posted to the registry on 20 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The Behavioral Effects of Opioids and Alcohol	11	10

Primary outcome: Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking

Time frame: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). Mean (Standard Error). Unit: score on a scale

Measure	Placebo/Placebo n = 10	Oxycodone 20mg/Placebo n = 10	Oxycodone 40mg/Placebo n = 10	Placebo/Alcohol 0.5g/kg n = 10	Placebo/Alcohol 0.8g/kg n = 10	Oxycodone 20mg/Alcohol 0.5g/kg n = 10	Oxycodone 20mg/Alcohol 0.8g/kg n = 10	Oxycodone 40mg/Alcohol 0.5g/kg n = 10	Oxycodone 40mg/Alcohol 0.8g/kg n = 10
Value	12.9 (8.6)	47.1 (9.4)	49.9 (7.9)	54.8 (8.8)	61.2 (8.2)	54.6 (9.4)	66.9 (9.4)	57.2 (9.1)	72.9 (7.2)

Population analysed: Per Protocol population, defined as participants completing the 9 experimental dosing conditions.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-Intervention / Days Off	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11
Qualification: Oxycodone 30mg / Placebo	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Placebo/Placebo	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Oxycodone 20mg/Placebo	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Oxycodone 40mg/Placebo	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Placebo/Alcohol 0.5g/kg	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Placebo/Alcohol 0.8g/kg	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Oxycodone 20mg/Alcohol 0.5g/kg	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Oxycodone 20mg/Alcohol 0.8g/kg	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Oxycodone 40mg/Alcohol 0.5g/kg	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Oxycodone 40mg/Alcohol 0.8g/kg	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. We have no plans to share individual participant data with other researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sharon L Walsh, PhD principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Alcohol and Opioid Agonist in people with Opioid Use and Alcohol Drinking, run by Sharon Walsh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking (time frame: These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04300751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.